Active Ingredient: Paclitaxel
Paclitaxel in combination with carboplatin is indicated for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy.
For this indication, competent medicine agencies globally authorize below treatments:
For:
From cycle 1 and thereafter
Intravenous, 100 milligrams paclitaxel per square meter of body surface, once every 7 days, 3 doses in total, over the duration of 21 days.
The recommended dose of paclitaxel is 100 mg/m² administered as an intravenous infusion over 30 minutes on Days 1, 8 and 15 of each 21-day cycle. The recommended dose of carboplatin is AUC = 6 mg•min/mL on Day 1 only of each 21-day cycle, beginning immediately after the end of paclitaxel administration.
Paclitaxel should not be administered on Day 1 of a cycle until absolute neutrophil count (ANC) is ≥1500 cells/mm³ and platelet count is ≥100,000 cells/mm³. For each subsequent weekly dose of paclitaxel, patients must have an ANC ≥500 cells/mm³ and platelets >50,000 cells/mm³ or the dose is to be withheld until counts recover. When counts recover, resume dosing the following week according to the criteria in Table 1. Reduce subsequent dose only if criteria in Table 1 are met.
Table 1. Dose reductions for haematologic toxicities in patients with non-small cell lung cancer:
| Haematologic Toxicity | Occurrence | Dose of paclitaxel (mg/m²)1 | Dose of carboplatin (AUC mg•min/ml)1 |
|---|---|---|---|
| Nadir ANC <500/mm³ with neutropenic fever > 38°C OR Delay of next cycle due to persistent neutropenia2 (Nadir ANC <1.500/mm³) OR Nadir ANC <500/mm³ for >1 week | First | 75 | 4.5 |
| Second | 50 | 3.0 | |
| Third | Discontinue Treatment | ||
| Nadir platelets <50,000/mm³ | First | 75 | 4.5 |
| Second | Discontinue Treatment | ||
1 On Day 1 of the 21-day cycle reduce the dose of paclitaxel and carboplatin simultaneously. On Days 8 or 15 of the 21-day cycle reduce the dose of paclitaxel; reduce the dose of carboplatin in the subsequent cycle.
2 Maximum of 7 days post scheduled Day 1 dose of next cycle.
For Grade 2 or 3 cutaneous toxicity, Grade 3 diarrhoea, or Grade 3 mucositis, interrupt treatment until the toxicity improves to ≤ Grade 1, then restart treatment according to the guidelines in Table 2. For ≥ Grade 3 peripheral neuropathy, withhold treatment until resolution to ≤ Grade 1. Treatment may be resumed at the next lower dose level in subsequent cycles according to the guidelines in Table 2. For any other Grade 3 or 4 non-haematologic toxicity, interrupt treatment until the toxicity improves to ≤ Grade 2, then restart treatment according to the guidelines in Table 2.
Table 2. Dose reductions for non-haematologic toxicities in patients with non-small cell lung cancer:
| Non-haematologic Toxicity | Occurrence | Dose of paclitaxel (mg/m²)1 | Dose of carboplatin (AUC mg•min/ml)1 |
|---|---|---|---|
| Grade 2 or 3 cutaneous toxicity Grade 3 diarrhoea Grade 3 mucositis ≥ Grade 3 peripheral neuropathy Any other Grade 3 or 4 non-haematologic toxicity | First | 75 | 4.5 |
| Second | 50 | 3.0 | |
| Third | Discontinue Treatment | ||
| Grade 4 cutaneous toxicity, diarrhoea, or mucositis | First | Discontinue Treatment | |
1 On Day 1 of the 21-day cycle reduce the dose of paclitaxel and carboplatin simultaneously. On Days 8 or 15 of the 21-day cycle reduce the dose of paclitaxel; reduce the dose of carboplatin in the subsequent cycle.
Administered as an intravenous infusion over 30 minutes.
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